MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO WINGED INFUSION SET

Catalog Number SV-23CLK

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number is not required for the reported product code.Codes: e-submitter has been experiencing difficulty with the codes at the time this report was packaged/submitted.We are actively working on resolving this issue with e-submitter.Codes will be provided in a follow up report.The actual device was returned to the manufacturing facility for evaluation.A total of twenty-seven (27) pieces were returned.Two (2) pieces were the actual device as the same event happened twice on the same canine patient on two (2) separate occupations, also see mdr 9681835-2017-00026.Visual inspection of the two actual devices found both needles to be placed inside the hubs and did not appeared to be loose.The needles were pinched by fingers and intentionally pulled and removed just above the glue on hub.No damages or bending were observed on the needle tube and its tip.The enclosed twenty-five unopened samples showed no indication of defective concerns, such as needle removal above glue or any potential factors of causing the similar reported incident.Simulation testing was conducted.According to the user, "the product was stored in a jar together with alcohol swabs".We prepared a bottle filled with alcohol solution (70%) and dipped unused samples in, let it stand for a day.After the samples were removed from alcohol on the following day needles were punctured into a rubber stopper to examine strength of the glue on hub by swinging in right & left motions and withdrawn from the hub.As a result, the samples were completely removed just above the glue and were being present on rubber stopper.When closely observed the glue area where the needles were removed simulated damage resembled the one observed in the actual devices.A manufacture inspection record check of the concerned lot, confirmed our assembly machine was to be operated under normal condition.Moreover, randomly picked inspection record per every lot showed no defective findings.There is no evidence this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, the simulation testing confirmed the actual samples were adversely affected by alcohol which may have chemically deteriorated glue's composition causing the reported events.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "dispose of safely after single use to avoid risk of infection".(b)(4).

Event Description

The user facility reported needle detachment during a procedure.Follow up communication with the user facility reported the following information: a maltese canine patient; the canine was administered a transfusion twice per day; during an in-home treatment a needle tube was removed from the component just above the glue on hub while the sharp tip was still being penetrated under the canines skin; a needle puncture was on the canines dorsocervical; the device was used several times and for a few days; and the needles were stored inside a jar together with alcohol swab.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the codes.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: SURFLO WINGED INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; reg. no. 9681835; 1727-1, tsuiji-arai, showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6876527
• MDR Text Key: 87802006
• Report Number: 9681835-2017-00027
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K771204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: SV-23CLK
• Device Lot Number: 160524A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1